CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART- octisalate, homosalate, oxybenzone, avobenzone, octocrylene cream

CLINIQUE by

Drug Labeling and Warnings

CLINIQUE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABS INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: octisalate 5.00% [] homosalate 5.00% [] oxybenzone 4.00% [] avobenzone 3.00% [] octocrylene 2.70%

INACTIVE INGREDIENT

inactive ingredients: water [] methyl trimethicone [] butylene glycol [] butyloctyl salicylate [] neopentyl glycol diheptanoate [] butyrospermum parkii (shea butter) [] peg-100 stearate [] silica [] dipentaerythrityl tri-polyhydroxystearate [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] dimethicone [] glyceryl stearate [] laurdimonium hydroxypropyl hydrolyzed soy protein [] rosmarinus officinalis (rosemary) extract [] perilla ocymoides leaf extract [] caffeine [] potassium cetyl phosphate [] sucrose [] styrene/acrylates copolymer [] c30-38 olefin/isopropyl maleate/ma copolymer [] cetyl alcohol [] vp/eicosene copolymer [] ethylhexylglycerin [] ammonium acryloyldimethyltaurate/vp copolymer [] peg-8 laurate [] sodium rna [] lecithin [] arginine ferulate [] tocopheryl acetate [] caprylyl glycol [] ascorbyl tocopheryl maleate [] propyl gallate [] stearic acid [] xanthan gum [] hexylene glycol [] nordihydroguaiaretic acid [] disodium edta [] phenoxyethanol [] sodium dehydroacetate [] mica

WHEN USING

 to use: apply liberally before sun exposure as needed. Reapply frequently, and after towel drying, swimming or perspiring

ASK DOCTOR/PHARMACIST

children under 6 months of age: ask a doctor

WARNINGS

warning: for external use only. keep out of eyes. rinse with water to remove.

STOP USE

stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children. if swallowed, get medical help right away.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

CLINIQUE

spf 30

WITH SOLAR SMART

UVA/UVB

ADVANCED PROTECTION

BODY CREAM

5 FL OZ/150 ML

clinique labs inc.

new york, ny 10022

INGREDIENTS AND APPEARANCE

CLINIQUE  SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART
octisalate, homosalate, oxybenzone, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-736
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUCROSE (UNII: C151H8M554)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-736-01	1 in 1 CARTON
1	NDC: 49527-736-02	150 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2010

Labeler - CLINIQUE LABS INC (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture